AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study

NCT05028660 | Completed

• 1 other identifier: ECD-AUR93A001
• Study Type: observational
• Target: 43
• Locations: 3 countries
• Sites: 5

Brief Summary

AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).

Conditions

Muscle-Invasive Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete response at the post-operative visit after RC.

  Percentage point difference in complete response rates between GAG favorable and GAG poor patients

  15 to 90 days after radical cystectomy surgery

Secondary Outcomes (2)

• Proportion of patients with recurrence at any time after treatment

  15 to 90 days after radical cystectomy surgery

• Proportion of complete responses after NAC according to CT-based RECIST v1.1

  15 to 90 days after radical cystectomy surgery

Study Arms (1)

Cohort 1

Sample size of approximately 47 patients with MIBC and elected for NAC

Diagnostic Test: GAG score

Interventions

GAG score DIAGNOSTIC_TEST

blood and urine samples to determine GAG scores

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll patients with MIBC elected for NAC, defined as: * MIBC: pathologically confirmed transitional cell carcinoma of the bladder with the invasion of the bladder muscular wall and no evidence of regional or distal metastases (T2-T4a cN0-N2 M0) * NAC: any choice of cisplatin-containing chemotherapeutic regimen.

You may qualify if:

• Histologically confirmed diagnosis of transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant \[50%+\] histology)
• Clinical stage T2-T4a N0-N2 M0 by CT (or MRI) + PET/CT
• Elected and fit according to institutional guidelines for cisplatin-based NAC followed by RC
• ECOG score 0-1

You may not qualify if:

• Previously intravenous chemotherapy for bladder cancer. (Patients who have had previous radiotherapy or concurrent chemo-radiation for bladder cancer are still eligible.)
• Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose NAC
• Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
• (A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower, Gleason score less/equal to 7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year before study allocation. Pathological evidence of concurrent T1a/b prostate cancer after radical cystecto-prostatectomy are still eligible.)
• \- Evidence of measurable nodal or metastatic disease.

Sponsors & Collaborators

• Elypta: lead
• Lund University: collaborator

Study Sites (5)

Zealand University Hospital

Roskilde, Denmark

Location

AOU Careggi

Florence, Italy

Location

IRCCS Ospedale San Raffaele, San Raffaele Hospital

Milan, Italy

Location

IRCCS Regina Elena

Rome, Italy

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and urine

Study Officials

• Francesco Gatto

  Elypta, Solna, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: July 21, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

IT (3); SE (1); DK (1)